Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

No text entered.

Reporting Groups

Description

Prasugrel: <75 Years of Age

Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age.

Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study.

Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.

Prasugrel: 75 Years of Age or Older

Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older.

Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study.

Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.

Clopidogrel: <75 Years of Age

Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age.

Commercially-available Aspirin : Low-dose aspirin, oral, as prescribed by physician through end of study

Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study

Clopidogrel: 75 Years of Age or Older

Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older.

Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study.

Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Prasugrel: <75 Years of Age

Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel : 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.

Prasugrel: 75 Years of Age or Older

Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.

Clopidogrel: <75 Years of Age

Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.

Clopidogrel: 75 Years of Age or Older

Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.

Total

Total of all reporting groups

Baseline Measures

Prasugrel: <75 Years of Age

Prasugrel: 75 Years of Age or Older

Clopidogrel: <75 Years of Age

Clopidogrel: 75 Years of Age or Older

Total

Number of Participants
[units: participants]

3620

1043

3623

1040

9326

Age
[units: years]Mean ± Standard Deviation

61.4
± 8.55

80.3
± 4.29

61.5
± 8.38

80.3
± 4.39

65.7
± 11.02

Gender
[units: participants]

Female

1309

520

1290

531

3650

Male

2311

523

2333

509

5676

Race/Ethnicity, Customized
[units: participants]

Caucasian

2362

767

2374

773

6276

African

87

14

72

12

185

Hispanic

321

109

346

86

862

Asian

821

147

800

164

1932

Other

29

6

30

5

70

Unknown

0

0

1

0

1

Region of Enrollment
[units: participants]

Portugal

18

11

14

11

54

Philippines

58

7

48

14

127

Taiwan

6

6

4

9

25

Slovakia

62

20

60

20

162

Greece

14

8

10

11

43

Costa Rica

5

1

2

2

10

Thailand

30

17

36

10

93

Ukraine

326

28

311

42

707

Chile

28

15

33

13

89

Italy

71

44

70

47

232

India

513

56

508

64

1141

France

29

22

29

19

99

Denmark

21

7

17

10

55

Korea, Republic of

35

7

33

7

82

Panama

29

7

24

10

70

Turkey

76

24

81

19

200

Czech Republic

37

31

32

38

138

Mexico

38

15

40

16

109

Canada

58

14

61

13

146

Brazil

154

27

147

34

362

Romania

103

26

105

23

257

Croatia

63

28

60

31

182

Sweden

4

3

6

1

14

United States

430

133

446

116

1125

Serbia

42

4

40

5

91

Spain

13

8

10

12

43

Ireland

5

4

6

3

18

Israel

75

33

85

21

214

Russian Federation

128

22

135

14

299

Colombia

40

21

45

17

123

Switzerland

6

4

4

6

20

Malaysia

35

7

33

9

84

Peru

58

19

67

12

156

Australia

13

6

15

7

41

South Africa

27

11

27

12

77

Netherlands

55

23

53

24

155

Tunisia

20

3

20

4

47

China

126

38

120

44

328

Finland

3

3

5

2

13

Lithuania

29

8

32

4

73

Austria

6

6

6

5

23

Malta

9

1

10

2

22

United Kingdom

33

21

40

12

106

Egypt

65

1

62

4

132

Hungary

86

43

87

44

260

Argentina

120

58

138

41

357

Poland

137

59

129

68

393

Belgium

7

7

7

8

29

Singapore

2

5

5

1

13

Bulgaria

216

48

209

55

528

Germany

46

20

46

21

133

New Zealand

10

3

10

3

26

History of Diabetes
[units: participants]

Yes

1393

363

1418

365

3539

No

2221

678

2193

675

5767

Unknown

6

2

12

0

20

History of Myocardial Infarction (MI)
[units: participants]

Yes

1556

426

1612

393

3987

No

2035

603

1988

633

5259

Unknown

29

14

23

14

80

History of Coronary Revascularization (PCI or CABG)
[1][units: participants]

Percentage of Participants With a Composite Endpoint of CV Death, MI, Stroke, or Re-hospitalization for Recurrent Unstable Angina (UA) [ Time Frame: Randomization through end of study (30-month visit) ]

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.